Agency IQ

SEPTEMBER 29, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 16, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

OCTOBER 27, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B. What ever happened to that thing?

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

FDA 40

FDA Science Regulations Production 40

Drug & Device Law

MAY 26, 2023

A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications. For instance, Sorsaia primarily involves a challenge to a state trying to prevent in-state use of an FDA-approved drug for its FDA-approved use.

Regulations 59

Regulations Production FDA FDA Approval 59

Drug & Device Law

JULY 24, 2023

Apparently, plaintiff’s statistician, in considering the post-2011 decline in Actos sales, did not deem it important that generic versions became available in August 2012. the relationship between [plaintiff] and its pharmacy benefit manager. . . We searched PATDC82 II for the word “generic” – it does not appear. 555, 565 (E.D.

Testimonials 52

Testimonials Pharmacy FDA Doctors 52

Drug & Device Law

JUNE 2, 2022

Even with some attempt to “stay in our lane,” we can see significant impacts on the legal framework in which a number of medical product manufacturers, to say nothing of distributors, pharmacies, and healthcare providers, operate. This is not a matter of us injecting our personal and political views into areas we do not belong.

FDA Approval 127

FDA Approval Pharmacy FDA Drugs 127